Kornimate/medical-research-clean huggingface dataset:
national tunisian registry of heart failure

Conditions: Heart Failure

Summary: nature-hf is an observational, multicentric and longitudinal study of heart failure performed with 100 tunisian cardiologists.

the nature-hf is a national clinical non-interventional registry of heart failure, carried out in tunisia at cardiology departments in hospitals and in liberal cardiology consultations. 100 cardiologists participate in the enrollment of the eligible patients as investigators. a committee of experts validates the protocol methodology and supervises the data-management. a steering committee helps investigators to monitor their patient inclusions, performs audit trails and prepares the statistical analysis plan for the study. collected data are managed by the dacima clinical suite®, the electronic data capture platform which complies with the fda 21 cfr part 11 requirements (food and drug administration 21 code of federal regulations part 11), the hipaa specifications (health insurance portability and accountability act), and the ich standards (international conference on harmonisation).

Eligibility criteria:
inclusion criteria: * patient with chronic heart failure * patient with acute heart failure (new onset or not) * the diagnosis of heart failure is at the discretion of the investigator * informed and signed consent exclusion criteria: * life expectancy \<12 months for extra cardiac disease * isolated right heart failure * pregnant woman * renal failure with creatinine clearance \< 15 ml / min * hemodialysis patients * cardiac surgery planned within 3 months * congenital heart disease

Keywords: heart failure acute heart failure chronic heat failure cardiovascular diseases heart diseases registry tunisia
lupus education alliance program

Conditions: Systemic Lupus Erythematosus; COVID-19

Summary: the purpose of this study is to evaluate the evaluate the effect of education-only vs. navigation interventions on covid-19 testing and vaccination for people with systemic lupus erythematosus.


Eligibility criteria:
inclusion criteria: * living with systemic lupus erythematosus (sle), * at least 18 years of age, * ability to speak and understand english, and * live, work, or seek care in alabama or louisiana
study of iv ym087 to assess efficacy and safety in patients with euvolemic or hypervolemic hyponatremia

Conditions: Hyponatremia

Summary: this study will investigate the application of a vasopressin antagonist in the treatment of hyponatremia most likely caused by inappropriate avp secretion. the population studied will include patients with euvolemic or hypervolemic hyponatremia.


Eligibility criteria:
inclusion criteria: * serum sodium levels 115 to \< 130meq/l * euvolemic or hypervolemic hyponatremia exclusion criteria: * clinical evidence of volume depletion or dehydration * untreated severe hypothyroidism, hyperthyroidism, or adrenal insufficiency * uncontrolled brady-or tachyarrhythmias requiring pacemaker placement or treatment

Keywords: hyponatremia hypervolemic euvolemic vasopressins ym087
assessment of assay for rapid identification of bloodstream infections from whole blood

Conditions: Bacteremia; Candidemia

Summary: the purpose of this study is to assess the effectiveness of rapid/bsi by testing its performance compared to blood cultures collected prospectively from consented subjects.


Eligibility criteria:
inclusion criteria: * determined to have a positive blood culture. exclusion criteria: -
psilocybin vs escitalopram for major depressive disorder: comparative mechanisms

Conditions: Depressive Disorder, Major

Summary: this is a randomised double-blind clinical trial. the aim is to compare the efficacy and mechanisms of action of psilocybin, the primary psychoactive substance in 'magic mushrooms', with the selective serotonin reuptake inhibitor (ssri) escitalopram for major depressive disorder (mdd).


Eligibility criteria:
inclusion criteria: 1. major depressive disorder (dsm-iv) 2. depression of moderate to severe degree (17+ on the 17-item hamilton depression scale (ham-d)). 3. no magnetic resonance imaging (mri) contraindications 4. no ssri contraindications 5. has a general practitioner (gp) or other mental healthcare professional who can confirm diagnosis 6. 18-80 years of age 7. males and females 8. sufficiently competent with english language key exclusion criteria: 1. current or previously diagnosed psychotic disorder 2. immediate family member with a diagnosed psychotic disorder 3. medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure e.g. creatine clearance:renal clearance (clrc) \< 30 ml/min etc.) 4. history of serious suicide attempts requiring hospitalisation. 5. significant history of mania (determined by study psychiatrist and medical records) 6. psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin, e.g. borderline personality disorder 7. blood or needle phobia 8. positive pregnancy test at screening or during the study, women who are planning a pregnancy and/or women who are nursing/breastfeeding. 9. participants who do not agree to use an acceptable contraceptive method throughout their participation in study. 10. current drug or alcohol dependence 11. no email access 12. use of contraindicated medication 13. patients presenting with abnormal qt interval prolongation at screening or with a history of this (qtc at screening above 440ms for men and above 470ms for women)

Keywords: depression mdd major depression major depressive disorder unipolar depression psilocybin psychedelics psychedelic escitalopram ssri
affect management intervention for early adolescents wtih mental health problems

Conditions: HIV Infections

Summary: adolescents are at risk for hiv because of sexual and drug use behavior initiated during early adolescence, and those with mental health problems appear to be particularly susceptible. problems with managing emotions may make it difficult for early adolescents to make good decisions about sexual and substance use behaviors. this project will develop and evaluate interventions for early adolescents with mental health issues. an intervention focused on teaching affect management skills will be compared to an intervention addressing a variety of health topics to determine which intervention best reduces risk behavior among this at-risk population.


Eligibility criteria:
inclusion criteria: * seventh graders identified by counselors at participating public school exclusion criteria: * adolescent is hiv positive * adolescent is developmentally delayed * adolescent in pregnant * adolescent has a history of sexual crime

Keywords: hiv prevention
a study of skb518 in patients with lung cancer

Conditions: Lung Carcinoma

Summary: this is an open-label, multicenter, phase ii study. the purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of skb518 in patients with lung cancer. eligible subjects will receive skb518 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 75 years old at the time of signing the informed consent form, applicable to both males and females. 2. non-small cell lung cancer (nsclc) or small cell lung cancer(sclc) confirmed by histology or cytology, who have failed first-line standard therapy. 3. at least one measurable tumor lesion per recist v1.1. 4. performance status score of 0-1 according to the eastern cooperative oncology group (ecog) scale. 5. expected survival period ≥ 12 weeks. 6. the function of important organs meets the requirements of the protocol. exclusion criteria: 1. symptomatic or uncontrolled cardiovascular disease 2. history of noninfectious pneumonitis/interstitial lung disease (ild) that required steroids or has current pneumonitis/ild; 3. subjects with the disease that requires systemic corticosteroid therapy (prednisolone or equivalent dose of similar drugs at a dose of \>10 mg/d) or other immunosuppressive therapy within 14 days before the first dose. 4. human immunodeficiency virus (hiv) positive or history of acquired immunodeficiency syndrome (aids); known active syphilis infection. 5. the investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study.
influence of aerobic exercise training (aet) on inflammatory bowel disease (ibd) in children and adolescents

Conditions: Ulcerative Colitis; Crohn Disease; Depression; Sleep; Quality of Life; Motor Activity

Summary: the purpose of this study is to determine if aerobic exercise training can serve as comprehensive palliative care, whereby enhancing cardiovascular fitness, mitigating depressive symptoms and augmenting sleep while bolstering health related quality of life in youth with crohn's disease and ulcerative colitis.

an aet intervention is designed to increase the aerobic fitness levels of ibd sufferers through daily activity, which is notably lower in this population and could be beneficial for sufferers managing this lifelong disease. with an increase in physical activity, the exergame aims to introduce, instill and integrate daily physical activity in the lives of ibd sufferers. the just dance kids exergame for nintendo wii employs moderate intensity physical activity and is well suited for this study. the exergame intervention protocol will comprise a ramped duration aerobic exercise training starting with 10 minutes in week 1 and rises to 30 minutes per session in weeks 5 through 8. just dance kids will be used by participants under the age of 11 and just dance for participants over the age of 10 due to the age appropriate dancing skill required in each game. the aim is to determine if this moderate intensity, 5 times per week exercise could decrease ibd flare-ups, improve cardiovascular fitness, reduce depressive symptoms, improve quality and quantity of sleep and improve the health-related quality of life in children and adolescents with ibd.

Eligibility criteria:
inclusion criteria: * aged 7 through 20 at start of study * willing and able to volunteer in the study * able to communicate and to complete questionnaires in german * have a functioning television with nintendo wii compatibility at home * provide participant written informed consent (when ≥11 years old at start of study) * provide parental/legal caregiver written informed consent (when participant is ≤17 years old at start of study) * provide oral informed consent (when ≤10 years old at start of study) exclusion criteria: * refusal to give necessary oral or written informed consent by patient and/or parent (legal caregiver) * not aged 7 through 20 at start of study * not willing and able to volunteer in the study * has sibling enrolled in this study * has severe physical diseases of the locomotor apparatus, psychotic disorders, severe affective disorders, eating disorders, mental retardation, autism spectrum disorder * inability to communicate and complete questionnaires in german * does not own a functional and nintendo wii-compatible television at home * among female adolescents, pregnancy, breastfeeding or intention to get pregnant during the study * has clinically significant cardiovascular disease * enrolment of the investigator, his/her family members, employees and other dependent persons

Keywords: aerobic exercise exercise exergame behavior video game inflammatory bowel disease children adolescents pediatric physical fitness
cchs secure health-hub advancing research efforts (cchs share)

Conditions: Congenital Central Hypoventilation Syndrome

Summary: the purpose of this study is to capture longitudinal natural history data in congenital central hypoventilation syndrome (cchs). this will include capturing standardized clinical data from standard of care assessments at several cchs referral centers. funding source-fda oopd

the natural history of a disease is how a disease progresses over time and impacts the lives of patients and their families. in congenital central hypoventilation syndrome (cchs), as in all rare diseases, collecting enough information to understand disease natural history is challenging. knowledge and data sharing is a key to overcoming this challenge. investigators at lurie children's are collaborating with teams at other cchs medical and research centers and patient advocacy groups to build a shared resource called the cchs secure health-hub advancing research efforts (cchs share). cchs share will advance knowledge of cchs natural history and guide future research studies and clinical trials. the purpose of this study is to collect and store cchs natural history data over the course of many years in cchs share. collected information will include patient and family self-reports surrounding their health and its impact on daily life, information collected during standard clinical care (medical records), family history, and other related information from patients. information in cchs share will be used for medical research to better understand cchs and to develop new treatments.

Eligibility criteria:
inclusion criteria: participants with a confirmed cchs diagnosis (confirmed alveolar hypoventilation and phox2b mutation testing results), of all ages and genders, who are followed clinically. exclusion criteria: an unconfirmed diagnosis of cchs or unconfirmed phox2b mutation or not followed clinically

Keywords: natural history rare disease
pharmacokinetics of flucloxacillin given by continuous or intermittent infusion to icu patients

Conditions: Bacterial Infections

Summary: the pharmacokinetics of flucloxacillin are expected to be different in icu patients compared to non-icu patients. the investigators will determine total and free flucloxacillin concentrations in 30 icu patients, who will get continuous (n=10) or intermittent infusion (n=20) of flucloxacillin as standard care. full pharmacokinetic curves will be taken for individual patients on the intermittent dosing regimen and limited sampling will be taken for individual patients on the continuous dosing regimen on day 2 and 4.

the pharmacokinetics of flucloxacillin are expected to be different in icu patients compared to non-icu patients. there is a substantial risk that present standard dosing regimens of antibiotics lead to suboptimal outcomes for patients on the icu. to prevent the risk of inadequate dosing in critically ill patients, it is important to optimize dosing regimens in icu patients. with this study the investigators will define pharmacokinetics of flucloxacillin in icu patients and search for variables influencing pharmacokinetics. by using population modeling the investigators will simulate different dosing regimens, intermittent and continuous, and compare probability of target attainment between continuous and intermittent infusion. to be able to include 30 patients within the study duration, a multi-centre approach is necessary. patients will receive standard care, as stated in the product characteristics or according to local protocols. minimally invasive blood sampling for pharmacokinetic analysis will be retrieved through a central venous catheter or an arterial line. full pharmacokinetic curves will be taken for individual patients on the intermittent dosing regimen and limited sampling will be taken for individual patients on the continuous dosing regimen on day 2 and 4.

Eligibility criteria:
inclusion criteria: 1. patient is admitted to an icu 2. subject is at least 18 years old on the day of the first dosing 3. is managed with a central venous catheter or arterial line 4. patient is treated with flucloxacillin exclusion criteria: 1. has previously participated in this trial

Keywords: pharmacokinetics flucloxacillin continuous infusion intensive care unit
circulating tumor cells and neutrophils count for colorectal metastatic cancer

Conditions: Metastatic Colorectal Cancer

Summary: colorectal cancer represents a major public health problem in france because of its high incidence and severe prognosis. early stages of the disease are well know and have justified the establishment of a mass screening strategy. unfortunately, the factors determining the progression to metastatic disease about them much harder to grasp. various prognostic factors and predictors of treatment response have been identified and are being used but most of them are in practice, they are sometimes coarse and relatively little discriminant for patients. it is now possible to directly quantify the amount of circulating tumor cells in peripheral blood. quantification of circulating tumor cells beyond a threshold of 3 cells/7,5 ml has been established as a major prognostic factor, and the rapid decrease in the number of these cells under treatment is also a predictor of response for patients suffering from metastatic colorectal cancer . furthermore, it has also been shown that the quality and importance of the systemic and peritumoral inflammatory response in carcinomas, including colorectal, played a key role in the prognosis of patients. in particular, the presence of high levels of blood neutrophils has been raised by many studies as being followed by a poorer prognosis. however, the correlation between the presence of circulating tumor cells and high levels of neutrophils has never been studied. there is a rational to assume that this association exists, and secondly that the presence of circulating tumor cells in a proinflammatory environment represented by a high levels of blood neutrophils promotes metastasis by exerting a negative synergistic effect on the prognosis of patients. the main objective of this pilot study is to find a correlation between the amount of circulating neutrophils and the presence of circulating tumor cells in patients with colon cancer metastatic unresectable non-pretreated. the secondary objective is to investigate whether this association results in a negative synergistic effect in terms of progression-free survival and survival to one year. this is a non-interventional study. the investigators expect the inclusion in one year of thirty patients in two centers (university hospital centre antoine lacassagne nice) to achieve these goals.


Eligibility criteria:
* inclusion criteria: * age \> 18 years * metastatic colorectal cancer * chemotherapy required * measurable scannographic target * ct-scan \< 3 weeks * written consent non-inclusion criteria : * personal history of invasive carcinoma * prior chemotherapy regimen * treatment with g-csf analogs * corticotherapy exclusion criteria: • consent withdrawal
auriculotherapy in tension-type headache due to temporomandibular dysfunction

Conditions: Tension-Type Headache

Summary: objectives: verify the effect of auriculotherapy in patients with tension-type headache resulting from temporomandibular dysfunction. design: randomized clinical study setting: randomized study participants: the study consist of 38 participants randomized into two groups: an intervention group (n = 18, sample loss = 1) and placebo group (n = 20, sample loss = 6) interventions: the intervention group will receive treatment with auricular acupuncture in the shen men, kidney, sympathetic, subcortex, adrenal and cerebral points. the placebo group will receive auriculotherapy in the trachea point. main outcome measures: visual analog scale for pain pain (vas) and surface electromyography (emg).

this is an experimental clinical trial in which will be selected at the university, 40 students with tension-type headache due to temporomandibular dysfunction. among the selected subjects will be randomized by blind draw into two groups: intervention group (ig) and placebo group (gii). the instruments that will be used for the evaluation are the visual analog pain scale, the survey questionnaire for temporomandibular disorders (rdc) 3, and surface electromyography (emg system of brazil). the emg signals will be collected in the rest position (3 samples) and maximum voluntary isometric contraction (3 collections). the masseter and temporalis muscles bilaterally will be evaluated according to the protocol of rodrigues. for treatment of ear, initially cleaning the pinna is made to be manipulated with 70% alcohol and later will be inserted mustard seed with a tape in the following points: shenmen, sympathetic, kidney, subcortex, adrenal and brain second souza in gi and gii point of the trachea. such treatment will last 15 minutes each session, being held 2 times a week, alternating the ear to be manipulated over a period of 5 weeks. for comparison between groups the mann-whitney test statistic with software biostat 4.0 software will be used. with a significance level (p \<0.05).

Eligibility criteria:
inclusion criteria: * individuals with tension-type headache due to temporomandibular dysfunction, aged 20 to 30 years, of both sexes exclusion criteria: * individuals with migraine type headache, secondary headaches * use of medicines more than 10 days per month and any type of acupuncture treatment in the last 12 months
an 'off-the-shelf' assistive listening device: normal-hearing children.

Conditions: Auditory Processing Disorder

Summary: the cochlea, the sensory organ of hearing, is a structure of the temporal bone on the skull. in everyday life sounds are heard via air conduction. this means that vibrations in the air are conducted through our ear canals, via the eardrum and the middle-ear bones, to the cochlea. however, vibrations can be conducted to the cochlea via the bones of the head. bone-conduction headsets have become popular for recreational use (for example cyclists and runners wear them to listen to music while exercising). when in a noisy environment, if a speech signal is delivered to a microphone connected via bluetooth to the bone conduction headset, the person wearing the headset receives the speech signal as if the talker were closer to them. the ratio between the speech level and the noise level (snr, signal-to-noise ratio) is increased, so that it is easier to understand the spoken message. a previous study carried out by the investigators has shown that this may help children with hearing loss due to otitis media with effusion ('glue ear'). the aim of the current study is to explore the potential of the headset to help children with auditory processing disorder (apd). typically, children with apd have normal audiograms, but, in spite of this, they struggle to understand speech in a background noise. the headset can deliver the speech message to them. currently, fm systems are used for children with apd in the classroom. these systems are effective, but their cost is high and provision may be limited. the feasibility of the use of the headset in a group of children with normal audiometric thresholds will be assessed. the study hypothesis is that using a bone-conduction headband improves speech recognition in noise and decreases listening effort even when air-conduction hearing thresholds are normal. measures of speech recognition and listening effort will be done in quiet and in noise with and without the bone-conduction headset in order to measure the effect of using the headset on speech recognition when hearing thresholds are normal.


Eligibility criteria:
inclusion criteria: 1. children aged 6 to 11 years old. 2. no developmental concerns 3. no concerns about hearing loss. 4. no concerns about language development. 5. english dominant language. exclusion criteria: 1. history, risk, or parent/carer/teacher concern of hearing loss. 2. developmental concerns 3. suspected language disability. 4. non-english dominant language.

Keywords: bone conduction assistive listening devices listening effort speech in noise